drugset / Trial / NCT00482092

Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

NCT00482092

Phase 3 Completed 330 enrolled Mesoblast, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.

Timeline

Start
2007-09-17
Primary completion
2014-09-15
Completion
2014-09-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prochymal® Cell therapy 600 cells Intravenous
Comparator Prochymal® Cell therapy 1200 cells Intravenous

Indications